Data Integrity Specialist

• Perform data integrity reviews across computerized systems, equipment, and supporting documentation.
• Examine audit trails and electronic records for unusual activity, unauthorized changes, missing information, or potential data manipulation.
• Review SOPs, user documentation, validation records, and other controlled documents for compliance and completeness.
• Assess data for accuracy, consistency, traceability, and overall reliability.
• Evaluate system access, user permissions, and controls surrounding electronic records.
• Review backup, recovery, and record-retention practices where applicable.
• Identify gaps between current processes and applicable regulatory or company requirements.
• Help determine the potential risk associated with compliance findings and recommend appropriate corrective actions.
• Partner with Quality, IT, laboratory, manufacturing, and other technical teams to investigate and resolve data-related issues.
• Prepare clear documentation of assessments, observations, risks, and recommended improvements.
• Support periodic reviews of equipment, systems, and processes to maintain an ongoing state of compliance.
• Stay current on evolving data integrity expectations and applicable FDA, GMP, GLP, and international regulatory requirements.

Qualifications:

• Bachelor's degree in a scientific, technical, quality, or related field preferred; equivalent experience will be considered.
• 3+ years of experience working in a regulated pharmaceutical, biotechnology, medical device, laboratory, or manufacturing environment.
• Working knowledge of GMP, GLP, GCP, or other regulated quality environments.
• Experience reviewing or creating SOPs, work instructions, technical documentation, or quality records.
• Understanding of data integrity principles, electronic records, audit trails, and controlled access.
• Strong analytical and investigative skills with the ability to identify inconsistencies and determine potential root causes.
• Comfortable working with Microsoft Office applications, including Word and Excel; experience with SharePoint or project-management tools is a plus.
• Strong written and verbal communication skills with the ability to clearly document findings and communicate with both technical and non-technical stakeholders.